U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines
  1. Search for FDA Guidance Documents

COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines May 1987

Final

POLICY:

There is no provision under the Federal Food, Drug, and Cosmetic Act which prohibits the sale of over-the-counter drug <> preparations in vending machines or in places other than drug stores. However, the article so vended must be in a full compliance with all the applicable sections of the Act.

The Act requires that certain mandatory labeling information must appear prominently, with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. This means that the prospective purchaser must have an opportunity to read and take such information into consideration in reaching a decision whether or not to make the purchase. The vending machine should therefore bear a complete copy of the required labeling for the article being offered for sale or the article should be displayed in such a manner that the mandatory labeling can be viewed by the prospective purchaser.

<> Indicates material has been deleted

Issued: 10/1/80
Revised: 5/22/87


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.